China NMPA issued the “Notice on Implementation of GB 9706.1-2020 and Supporting Standards”, equivalent to IEC60601 on March 16, 2023, with effective date of May 1, 2023. Good news is that, for active product manufacturers with existing NMPA certificates, grace period has been granted to comply by December 31, 2025.
The Impact of GB 9706.1-2020 and Supporting Standards in China
GB 9706.1-2020 and supporting standards are mandatory standards for medical electrical equipment.
If the related new standards’ effective date is prior to Dec 31, 2025, there are different scenarios:
- Since the effective date of new standards, for initial registration of Class II and Class III submission, all new testing reports shall meet the requirements of the new 9706 (IEC60601) standards. If having submitted application prior to the new standards’ effective date and got NMPA receipt notice, manufacturers can follow the old standards to do the testing for device registration.
- For manufacturers with existing certificates, testing for the registration required to meet GB 9706 standards is extended to a 3-year period. They need to submit new testing reports in comply with the new GB 9706 standards (IEC 60601), and complete modification registration within 3 years after the new standards’ effective date.
For the second scenario above, NMPA further explains:
- For products where there are applicable standards, if the implementation date specified in the standards is May 1, 2024, the modification registration should be completed by May 1, 2027
- For products where there is no applicable standard, or the implementation date of the applicable standard is May 1, 2023, the modification registration should be before completed by May 1, 2026.
Please be advised that, the new standards require risk management documents and other materials that China testing centers are not used to cope with. It will take a long time to complete manufacturers’ necessary tests.
Testing Requirements
- The testing report can be submitted by either entrusted testing center or registrants.
- If entrusted testing centers that do not meet all the new standard testing qualifications, they may subcontract testing.
- For major issues such as basic performance and model typical description, relevant opinions shall be included in the testing report for NMPA reference.
Click HERE for our comprehensive review on the standard GB 9706.1-2007, equivalent to IEC 60601-1.
What are the New Medical Electrical Equipment Standards?
The new version of GB 9706 standards composes of 69 standards, among them 67 are mandatory standards. They include but are not limited to the following:
- Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Parallel standard: electromagnetic compatibility Requirements and tests
- Medical Electrical Equipment Part 1-8: General Requirements for Basic Safety and Basic Performance Parallel Standards: General Requirements, Testing and Guidelines for Medical Electrical Equipment and Alarm Systems in Medical Electrical Systems
- Medical Electrical Equipment Part 1-11: General Requirements for Basic Safety and Essential Performance Tied Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in Home Care Environments
- Medical Electrical Equipment Part 1-12: General Requirements for Basic Safety and Basic Performance Tied Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Expected to Be Used in Emergency Medical Services Settings
- Medical electrical equipment Part 1-3: General requirements for basic safety and basic performance Parallel standard: radiation protection for diagnostic X-ray equipment
- Safety requirements for electrical equipment for measurement, control and laboratory use Part 4: Special requirements for sterilizers and washer-disinfectors for handling medical materials
- … …
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